Palisade Bio, Inc. - PALI STOCK NEWS

Palisade Bio (NASDAQ: PALI) has initiated its Phase 1 clinical study of PALI-2108, dosing its first subject. The study evaluates an orally administered PDE4 inhibitor prodrug for treating moderate-to-severe Ulcerative Colitis (UC). The single-center, double-blind, placebo-controlled study will assess safety, tolerability, pharmacokinetics, and pharmacodynamics in both healthy volunteers and UC patients. The study includes single ascending dose (SAD) cohorts, food effect evaluation, multiple ascending dose (MAD) cohorts, and a UC patient cohort. Topline data is expected in first half of 2025.

Palisade Bio (NASDAQ: PALI) has presented positive data from two ex vivo translational studies of PALI-2108, their colon-specific PDE4 inhibitor prodrug for ulcerative colitis treatment. The studies demonstrated successful bioactivation in stool samples and significant TNFα inhibition in whole blood. PALI-2108 achieved a 90.1% conversion rate at 24 hours and showed 20-fold higher potency compared to apremilast. The drug's targeted activation in the colon aims to minimize systemic exposure and side effects. The company plans to initiate Phase 1 clinical trials before year-end, including studies with healthy volunteers and UC patients.

Palisade Bio (Nasdaq: PALI) has received a No Objection Letter from Health Canada for its Phase 1 clinical study of PALI-2108, an oral PDE4 inhibitor prodrug for treating Ulcerative Colitis (UC). The study will evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy volunteers and UC patients. The trial design includes Single Ascending Dose (SAD), Multiple Ascending Dose (MAD), and food effects (FE) cohorts, with approximately 90 patients planned for enrollment.

The primary objective is to assess safety and tolerability, with secondary objectives focusing on pharmacokinetics. Exploratory objectives include examining PDE4-related biomarkers and UC-specific markers. Palisade Bio aims to commence site initiation and enrollment before year-end. The company believes PALI-2108 could be the first approved PDE4 inhibitor for UC, addressing a significant medical need in a market expected to reach nearly $10 billion by 2028.

Palisade Bio, Inc. (Nasdaq: PALI) has announced its participation in the 2024 Maxim Healthcare Virtual Summit, presented by Maxim Group The company's CEO, J.D. Finley, and CMO, Dr. Mitch Jones, will engage in a fireside chat on Tuesday, October 15th at 4:30 PM ET.

Palisade Bio is a biopharmaceutical company dedicated to developing novel therapeutics for patients with autoimmune, inflammatory, and fibrotic diseases. The summit will feature presentations and interactive discussions with CEOs and key management from various healthcare sectors, including biotechnology, diagnostics, medical devices, and healthcare information technology.

Interested parties can attend the virtual event by signing up for M-Vest membership. The summit promises to offer timely and engaging industry panels alongside company presentations.

Palisade Bio (Nasdaq: PALI) has made significant progress towards launching its Phase 1 human clinical study for PALI-2108, a locally activated PDE4 inhibitor prodrug for treating ulcerative colitis (UC). The company has:

1. Completed nonclinical safety and toxicity studies
2. Finalized Phase 1 clinical trial design
3. Established Maximum Recommended Starting Dose
4. Completed pre-Clinical Trial Application (CTA) meeting with Health Canada
5. Submitted the CTA for the Phase 1 study

The Phase 1 study will be a single-center, double-blind, placebo-controlled study focusing on safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy volunteers and UC patients. Palisade Bio plans to enroll approximately 90 patients across various cohorts and remains on track to initiate the study before year-end.

Palisade Bio (Nasdaq: PALI) has launched a new corporate branding and website, reaffirming its commitment to developing next-generation precision therapies for autoimmune, inflammatory, and fibrotic diseases. The company's lead program, PALI-2108, targets moderate-to-severe ulcerative colitis and is advancing towards a Phase 1 clinical study before year-end. Palisade Bio plans to use advanced machine learning to identify patients with elevated PDE4 activity, potentially enhancing treatment efficacy. The company is also developing PALI-1908 for fibro stenotic Crohn's Disease. CEO J.D. Finley expressed confidence in the company's progress and upcoming milestones, emphasizing the potential to address significant unmet medical needs in established commercial markets.

Palisade Bio (Nasdaq: PALI) has reported promising data on PDE4B expression as a potential marker for patient stratification in Ulcerative Colitis (UC) treatment. The company's analysis, conducted in collaboration with Strand Life Sciences, revealed that 70% of adult colitis patients and 90% of pediatric colitis patients show PDE4B expression above a specific threshold. This finding could significantly improve patient selection for targeted therapies.

Palisade is advancing its lead program PALI-2108, an oral colon-specific PDE4 inhibitor prodrug for UC treatment. A Phase 1 clinical study is set to begin before year-end. Preclinical studies in a DSS-induced UC mouse model demonstrated PALI-2108's potential efficacy, showing reduced PDE4B expression, increased cAMP levels, and decreased inflammatory markers with increasing doses.

Palisade Bio (Nasdaq: PALI), a biopharmaceutical company focusing on autoimmune, inflammatory, and fibrotic diseases, has announced an inducement grant under Nasdaq Listing Rule 5635(c)(4). The company's Compensation Committee approved an option grant for 5,000 shares of common stock to Joerg Heyer, the new Head of Translational Science and Medicine, as a material inducement to employment.

The option, issued on August 16, 2024, has an exercise price of $3.94, matching the closing price of Palisade's common stock on the grant date. The option will vest quarterly over three years, contingent on Mr. Heyer's continued service to the company.

Palisade Bio (Nasdaq: PALI) reported Q2 2024 financial results and provided a business update. Key highlights include:

1. Progress towards Phase 1 clinical study of PALI-2108 for Ulcerative Colitis (UC) before year-end
2. Completed microbiome study and nonclinical IND/CTA-enabling studies
3. Expanded global IP portfolio with European patent grant
4. Completed first GMP batch of PALI-2108
5. Advanced collaboration with Strand Life Sciences on PDE4-related biomarkers
6. Received Canadian patent allowance for PALI-2108

Financial results: $11.4M cash on hand, sufficient through Q1 2025. Net loss of $4.1M, up from $3.4M in Q2 2023. R&D expenses increased 21% to $2.6M, while G&A expenses rose 11% to $1.6M.